MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ADAPTOR BIOPSY VALVE; SINGLE USE ADAPTER BIOPSY VALVE

Model Number	MAJ-1414
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
In speaking with olympus technical support via the phone, the olympus representative had stated the single use adaptor biopsy valve was part of a kit and the customer discarded the needle in the kit, however the single use adaptor biopsy valve would be returned to olympus.The subject device referenced in this report was not returned for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.Investigation activities have been opened to manage the actions related to this issue and any required mdr reporting.
Event or Problem Description
It was reported by the olympus representative, at the beginning of a diagnostic endobronchial ultrasound bronchoscopy (ebus), the single use adaptor biopsy valve was leaking.The single use adaptor biopsy valve was used with evis exera ii ultrasonic bronchofibervideoscope and the single use aspiration needle.The procedure was completed using the same device with no delay and no patient injury.The device had been inspected prior to use and was found to be intact.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the approved final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, and since the device was not returned for evaluation, the definitive root cause of the reported issue could not be determined.Olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
This report is being submitted for h4: manufactured in february 2021.

• Brand Name: SINGLE USE ADAPTOR BIOPSY VALVE
• Common Device Name: SINGLE USE ADAPTER BIOPSY VALVE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 12283106
• Report Number: 8010047-2021-09837
• Device Sequence Number: 14372922
• Product Code: PSV
• UDI-Device Identifier: 04953170181009
• UDI-Public: 04953170181009
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K050503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MAJ-1414
• Device Lot Number: 12V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2021
• Supplement Date Received by Manufacturer: 04/26/2022; 06/14/2022
• Initial Report FDA Received Date: 08/05/2021
• Supplement Report FDA Received Date: 05/26/2022; 06/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BF-UC180F SCOPE, SN # (B)(6).; NA-201SX-4021 ASPIRATION NEEDLE, SN # (B)(6).
• Patient Sex: Unknown